Femoston

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Femoston (Femoston 2/10)

2 mg (brick-red), 2 mg + 10 mg (yellow), coated tablets

Estradiolum, Estradiolum + Dydrogesteronum
Femoston and Femoston 2/10 are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Femoston and what is it used for
• 2. Important information before taking Femoston
• 3. How to take Femoston
• 4. Possible side effects
• 5. How to store Femoston
• 6. Contents of the packaging and other information

1. What is Femoston and what is it used for

Femoston is a medicine used in Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen called estradiol and a progestogen called dydrogesterone.
Femoston is indicated for use in women who have symptoms of a lack of female sex hormones (estrogens) and who have had their last menstrual period at least 6 months ago.

Femoston is used for the following purpose:

Treatment of symptoms occurring after menopause.

During menopause, the amount of estrogen produced in a woman's body decreases. This can cause symptoms such as hot flashes in the face, neck, and chest. Femoston alleviates symptoms in postmenopausal women. Femoston is prescribed if these symptoms significantly interfere with daily life.

Prevention of osteoporosis

In some postmenopausal women, bone fragility (osteoporosis) may occur. All available treatment methods should be discussed with a doctor.
In the case of an increased risk of fractures due to osteoporosis and when the patient cannot take other medicines, Femoston can be used to prevent osteoporosis in postmenopausal women.

2. Important information before taking Femoston

Medical history and regular check-ups

The use of HRT carries risks that need to be considered when deciding to start or continue treatment.
Experience in treating women with premature menopause (due to ovarian dysfunction or after ovarian surgery) is limited. In the case of premature menopause, the risk of using HRT may be different. A doctor should be consulted.
Before starting (or re-introducing) HRT, the doctor should conduct a medical history with the patient, including a family history. The doctor may decide to perform additional tests, including a breast examination and/or gynecological examination, if deemed necessary.
After starting Femoston, you should visit your doctor for regular check-ups (at least once a year). During these check-ups, you should discuss the benefits and risks associated with continuing to take Femoston with your doctor.
Regular breast screening should be performed in accordance with the doctor's recommendations.
DO NOT TAKE FEMOSTONif you have or have had any of the following symptoms or medical conditions. If you are unsure about any of the following symptoms or medical conditions before taking Femoston, you should consult a doctor.

When not to take Femoston

• if breast cancer has been diagnosed, has occurred in the past, or is suspected by the doctor
• if there is or is suspected to be a tumor that grows in response to estrogens, such as endometrial cancer (cancer of the endometrium)
• if there is or is suspected to be a tumor that grows in response to progestogens
• if you have or have ever been diagnosed with a meningioma (usually a benign brain tumor)
• if you have vaginal bleeding of unknown cause
• if you have untreated endometrial hyperplasia(abnormal thickening of the lining of the uterus)
• if you have or have had blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• if you have or have recently had a blood clot-related disease, such as a heart attack, stroke, or coronary artery disease
• if you have or have had liver disease, and liver function tests have not returned to normal
• if you have a rare, inherited blood disorder called porphyria
• if you are allergic (hypersensitive) to estradiol, dydrogesterone, or any of the other ingredients of Femoston (listed in section 6).

If any of the above conditions occur for the first time while taking Femoston, you should stop taking it and consult a doctor immediately.

Warnings and precautions

Before starting treatment, you should inform your doctor if you have ever had any of the following problems, as they may recur or worsen while taking Femoston. If you have ever had any of the following problems, you should have more frequent medical check-ups:

• uterine fibroids
• endometriosis (growth of endometrial tissue outside the uterus) or a history of endometrial hyperplasia
• risk factors for blood clots (see "Blood clots in veins (thrombosis)")
• increased risk of estrogen-dependent cancer (family history of breast cancer)
• high blood pressure
• liver disease, such as benign liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (an immune system disease that affects many organs)
• epilepsy
• asthma
• otosclerosis (a disease that affects the eardrum and impairs hearing)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary and acquired angioedema.

YOU SHOULD STOP TAKING FEMOSTON AND CONSULT A DOCTOR IMMEDIATELYif you experience any of the following symptoms while taking HRT:

• any of the conditions listed in "When not to take Femoston"
• jaundice (yellowing of the skin or eyes) - this may be a sign of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, in combination with difficulty breathing - this may be a sign of angioedema
• significant increase in blood pressure (symptoms may include headaches, fatigue, dizziness)
• migraine headaches that occur for the first time
• pregnancy
• symptoms of blood clots, such as painful swelling and redness of the legs, sudden chest pain, difficulty breathing. See "Stop taking Femoston and consult a doctor immediately".

NOTE:Femoston does not have a contraceptive effect. If it has been less than 12 months since your last menstrual period and you are under 50 years old, you may need to use additional contraception to prevent pregnancy. You should consult a doctor.

HRT and cancer

Estrogen-only HRT increases the risk of endometrial hyperplasiaand endometrial cancer.
The progestogen in Femoston protects against this additional risk.

Unexpected bleeding

While taking Femoston, you will experience monthly bleeding (so-called withdrawal bleeding). However, if you experience unexpected bleeding or spotting that:

• lasts longer than the first 6 months of treatment
• starts after 6 months of treatment
• continues after stopping Femoston you should consult a doctor as soon as possible.

Breast cancer

Data confirm that taking combined estrogen-progestogen HRT or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long you take HRT. This additional risk becomes apparent after 3 years of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
Comparison
In women aged 50-54 who do not take HRT, breast cancer will be diagnosed in approximately 13-17 out of 1000 women over a 5-year period.
In women aged 50 who start 5-year estrogen-only HRT, the number of cases will be 16-17 out of 1000 patients (i.e., 0-3 additional cases).
In women aged 50 who start 5-year combined estrogen-progestogen HRT, the number of cases will be 21 out of 1000 patients (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer will be diagnosed in approximately 27 out of 1000 women over a 10-year period.
In women aged 50 who start 10-year estrogen-only HRT, the number of cases will be 34 out of 1000 patients (i.e., 7 additional cases).
In women aged 50 who start 10-year combined estrogen-progestogen HRT, the number of cases will be 48 out of 1000 patients (i.e., 21 additional cases).

You should have regular breast examinations. You should consult a doctor if you notice any changes, such as:

• indentation of the breast skin
• changes in the nipple area
• any visible or palpable lumps

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that includes only estrogens or a combination of estrogens and progestogens is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed over a 5-year period in approximately 2 out of 2000 women. In women who have taken HRT for 5 years, it will occur in approximately 3 out of 2000 women (i.e., approximately 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in veins (thrombosis)

The risk of blood clots in veins is 1.3-3 times higher in women taking HRT than in those not taking HRT, especially during the first year of treatment.
The formation of blood clots can have serious consequences. If they move to the lungs, they can cause chest pain, shortness of breath, fainting, or even death.
The risk of blood clots in veins increases with age and if you have any of the following conditions. You should inform your doctor if you have any of the following conditions:

• inability to walk for a long period due to major surgery, injury, or illness (see also section 3 "Planned surgery")
• you are significantly overweight (BMI >30 kg/m)
• you have problems with blood clotting that require long-term treatment with anticoagulant medicines
• you have a history of blood clots in the veins of the legs, lungs, or other organs
• you have systemic lupus erythematosus
• you have cancer.

Symptoms of blood clots, see "Stop taking Femoston and consult a doctor immediately".
Comparative data
In women aged 50-60 who do not take HRT, blood clots in veins will occur in approximately 4-7 out of 1000 women over a 5-year period.
In women aged 50-60 who take combined estrogen-progestogen HRT for more than 5 years, 9-12 cases will occur out of 1000 women (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.
In women over 60 taking combined estrogen-progestogen HRT, there is a slightly increased risk of heart disease compared to those not taking HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in women taking HRT than in those not taking HRT.
The number of additional stroke cases due to HRT increases with age.
Comparison
In women aged 50-60 who do not take HRT, stroke will occur in approximately 8 out of 1000 women over a 5-year period. In women aged 50-60 who take HRT for more than 5 years, 11 cases will occur out of 1000 women (i.e., 3 additional cases).

Meningioma

Taking Femoston is associated with the development of a usually benign brain tumor (meningioma). If a meningioma is diagnosed, the doctor will stop Femoston treatment (see "When not to take Femoston"). If you experience any symptoms such as vision disturbances (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, weakness in the arms or legs, you should consult a doctor immediately.

Other conditions

HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start HRT at an age over 65. You should consult a doctor.

Children

Femoston is indicated only for women with symptoms of a lack of female sex hormones (estrogens), who have had their last menstrual period at least 6 months ago.

Femoston and other medicines

Some medicines may affect the action of Femoston. This may cause irregular bleeding. These include:

• medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines for tuberculosis (such as rifampicin, rifabutin)
• medicines for HIV infection (AIDS) (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal medicines containing St. John's Wort (Hypericum perforatum). HRT may affect the action of other medicines:
• an antiepileptic medicine (lamotrigine), as this may increase the frequency of seizures
• a combination treatment for hepatitis C virus (HCV) infection (e.g., ombitasvir/paritaprevir/ritonavir with dasabuvir or without dasabuvir, and a treatment regimen using glecaprevir/pibrentasvir) may increase liver function test results in the blood (increased ALT enzyme activity) in women taking combined hormonal contraceptives containing ethinyl estradiol. Femoston contains estradiol instead of ethinyl estradiol. It is not known whether increased ALT enzyme activity may occur when taking Femoston with such a combination treatment regimen.

While taking Femoston, the following medicines may have dangerously high blood levels:

• tacrolimus, cyclosporin - used, for example, after organ transplantation
• fentanyl - a pain reliever
• theophylline - used in asthma and other breathing problems.

Therefore, it may be necessary to carefully monitor the level of the medicine and adjust the dose of the medicine.
You should tell your doctor or pharmacist about all other medicines you are currently taking or have recently taken, including those available without a prescription, herbal medicines, or other natural remedies (e.g., dietary supplements). Your doctor will provide you with appropriate guidance.

Blood tests

Before a blood test, you should inform your doctor or laboratory staff that you are taking Femoston, as this medicine may affect the results of some laboratory tests.

Femoston with food and drink

Femoston can be taken with or without food.

Pregnancy and breastfeeding

Femoston is indicated only for women with symptoms of a lack of female sex hormones (estrogens), who have had their last menstrual period at least 6 months ago.

• If pregnancy is suspected, you should stop taking Femoston and consult a doctor. Femoston is not indicated during breastfeeding.

Driving and using machines

No studies have been conducted on the effect of Femoston on driving or using machines. Such an effect is unlikely.

Femoston contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult a doctor before taking this medicine.

3. How to take Femoston

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

When to start taking Femoston

You should not start Femoston before at least 6 months have passed since your last natural menstrual period.
Treatment with Femoston may be started on any day, if:

• you are not currently taking hormone replacement therapy
• you are changing from another HRT product to a continuous combined HRT product. This regimen involves taking a tablet or applying a patch that contains both estrogen and progestogen every day.

Treatment with Femoston may be started after completing a 28-day menstrual cycle, if:

• you are changing from a cyclic or sequential HRT product. This regimen involves taking a tablet or applying a patch that contains estrogen alone for the first part of the cycle, followed by a tablet or patch that contains both estrogen and progestogen for the next 14 days.

Taking Femoston

• Swallow the tablet with water.
• Tablets can be taken with or without food.
• You should try to take the tablet at the same time every day. This will help keep a constant level of the medicine in your body. It will also help you remember to take the tablet.
• You should take 1 tablet every day, without interruption between packs. The blister pack is marked with symbols for the days of the week to help you remember when to take the tablet (translation of the day symbols on the packaging is at the end of the leaflet and on the sachet included with the packaging).

How much to take

• Your doctor will prescribe the lowest effective dose for the shortest necessary period to treat your symptoms. You should consult your doctor if the dose seems too strong or too weak for you.
• When taking Femoston to prevent osteoporosis, your doctor will adjust the dose individually according to your needs, based on your bone mass.
• You should take 1 brick-red tablet every day for the first 14 days, followed by 1 yellow tablet every day for the remaining 14 days. The 28-day treatment cycle is indicated on the calendar included in the packaging.

Planned surgery

• In the case of planned surgery, you should inform the surgeon that you are taking Femoston. It may be necessary to stop taking Femoston for about 4-6 weeks before the planned surgery to reduce the risk of blood clots (see section 2 "Blood clots in veins (thrombosis)"). You should ask your doctor when you can restart Femoston.

Taking more Femoston than prescribed

If you (or someone else) take too many Femoston tablets, it is unlikely to cause harm. You may experience nausea, vomiting, breast tenderness or pain, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding. No additional treatment is necessary, but if you are concerned, you should consult a doctor.

Missing a dose of Femoston

You should take the missed tablet as soon as possible. If more than 12 hours have passed since the time you should have taken the tablet, you should take the next tablet at the scheduled time without taking the missed tablet. You should not take a double dose to make up for the missed dose. You may experience bleeding or spotting.

Stopping Femoston

You should not stop taking Femoston without consulting a doctor.

• If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Femoston can cause side effects, although not everybody gets them.
The following diseases have been reported to occur more frequently in women taking HRT than in those not taking HRT:

• breast cancer
• endometrial hyperplasiaor cancer of the endometrium
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism, pulmonary embolism)
• heart disease
• stroke
• possible memory loss, if HRT is started at an age over 65.

For more information on these side effects, see section 2.
The following side effects may occur while taking Femoston:

Very common (may affect more than 1 in 10 people):

• headaches
• abdominal pain
• back pain
• breast tenderness or pain.

Common (may affect up to 1 in 10 people):

• vaginal candidiasis (vaginal infection with Candida albicansfungus)
• depression, nervousness
• migraine. If you experience migraine headaches for the first time, you should stop taking Femoston and consult a doctor immediately
• dizziness
• nausea (feeling sick), vomiting, bloating (gas)
• allergic skin reactions (such as rash, severe itching, hives)
• bleeding disturbances, such as irregular bleeding or spotting, painful periods, heavy or light bleeding
• pelvic pain
• discharge
• feeling weak, tired, and unwell
• swelling of the ankles, feet, or fingers (peripheral edema)
• weight gain.

Uncommon (may affect up to 1 in 100 people):

• uterine fibroids may increase in size
• allergic reactions, such as shortness of breath (asthma) or other whole-body reactions, such as nausea, vomiting, diarrhea, or low blood pressure
• changes in libido
• blood clots that cause blockages in the blood vessels of the legs or lungs (venous thromboembolism or pulmonary embolism)
• liver function disorders, sometimes with jaundice, feeling unwell, or abdominal pain. If you experience yellowing of the skin or eyes, you should stop taking Femoston and consult a doctor immediately
• gallbladder disease
• breast swelling (breast edema)
• premenstrual syndrome
• weight loss.

Rare (may affect up to 1 in 1000 people):

• heart attack
• swelling of the face, tongue, and/or throat, making it difficult to breathe (angioedema)
• purple spots and patches on the skin (purpura).

Other side effects have been reported during treatment with HRT, including Femoston, with an unknown frequency:

• benign or malignant tumors that may be dependent on estrogen levels, such as endometrial cancer(cancer of the endometrium), ovarian cancer (see section 2 for more information)
• increased size of tumors that may be dependent on progestogen levels (such as meningioma)
• a disease in which red blood cells are broken down (hemolytic anemia)
• an immune system disease that affects many organs (systemic lupus erythematosus)
• increased frequency of seizures (epilepsy)
• involuntary muscle contractions (chorea)
• blood clots in the arteries (arterial thrombosis)
• pancreatitis, in women with previously elevated levels of certain fats in the blood (hypertriglyceridemia)
• various skin disorders: skin discoloration, especially on the face and neck, known as "pregnancy spots" (chloasma), painful red skin lumps (erythema nodosum), rash in the shape of red rings or blisters (erythema multiforme)
• leg cramps
• urinary incontinence
• breast pain/lumps (fibrocystic breast changes)
• cervical erosion
• worsening of symptoms of a rare disease affecting the blood pigment (porphyria)
• high levels of certain fats in the blood (hypertriglyceridemia)
• changes in the cornea of the eye (corneal edema), inability to wear contact lenses (intolerance to contact lenses)
• increased levels of thyroid hormones.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Femoston

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Femoston contains

• The active substances of Femoston are estradiol (in the form of estradiol hemihydrate) and dydrogesterone.
• each brick-red tablet contains 2 mg of estradiol (in the form of estradiol hemihydrate);
• each yellow tablet contains 2 mg of estradiol (in the form of estradiol hemihydrate) and 10 mg of dydrogesterone.
• Other ingredients are lactose monohydrate, hypromellose, cornstarch, colloidal anhydrous silica, magnesium stearate. Coating: Opadry OY-6957 (pink tablets): hypromellose, talc, macrogol 400, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172). Coating: Opadry OY-02B2264 (yellow tablets): hypromellose, talc, macrogol 400, titanium dioxide (E 171), iron oxide yellow (E 172).

What Femoston looks like and contents of the pack

• The tablets are round, biconvex, and have "379" embossed on one side. Each pack contains 28 tablets.
• Femoston contains tablets in two colors. Each blister pack contains 14 brick-red tablets (for the first 14 days of the cycle) and 14 yellow tablets (for the next 14 days of the cycle).
• The tablets are packaged in PVC/Al blisters in a cardboard box.
• The pack contains 28 coated tablets.

A cardboard sachet is included with the packaging, which should be placed in the blister pack.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

THERAMEX IRELAND LIMITED
3rd Floor, Kilmore House
Park Lane, Spencer Dock
Dublin 1
Ireland

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
Netherlands

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Romania, the country of export:
15178/2023/01
15178/2023/02
Parallel import authorization number: 193/20
Translation of the day symbols on the packaging:
Luni – Monday
Mar – Tuesday
Mie – Wednesday
Joi – Thursday
Vin – Friday
Sâm – Saturday
Dum – Sunday

Date of approval of the leaflet: 01.07.2025

[Information about the trademark]